Biologics, Manufacturing & Distribution, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients
The Regulatory Affairs Leader will be responsible for supporting clients, US and EU regulatory submission strategies. He/She will be responsible for drafting and reviewing submission documents and interacting with our clients.
Key Responsibilities include, but are not limited to:
Support our clients with required documents for CMC sections of regulatory submissions.
Determine and communicate submission and approval requirements early in the product lifecycle to assure that project plans are aligned with submission strategies and regulatory guidelines.
Write and review regulatory documents with a critical eye for suitability for submissions to FDA and any other regulatory agencies as need be.
Under the direction of the VP of Quality and Regulatory Affairs, handle the preparation of submission packages for regulatory agencies in compliance with applicable requirements & best practices. Identify issues early in the submission preparation process that could impact timelines/risks.
Participate in multidisciplinary project teams within the client providing guidance and direction on current regulatory pathways and expectations.
Assist with the companies progress into commercial readiness efforts
Stay current on changes to the regulatory environment that could impact Paragon’s contract manufacturing strategies.
Monitor applications under review, manage and track submission and maintenance processes to support regulatory applications.
Bachelor's Degree in a scientific or engineering discipline
10 or more years in Regulatory Affairs in the area of Biologics
Experience in the hands-on preparation of IND, IMPD or BLA submissions for Biological products
Interactions with the US, Canadian, European, and other international regulatory authorities
Prior facilitation of face-to-face meetings with regulators
Ability to build credibility and influence internal departments and client representatives
Experience in working with regulatory consultants and contract research organizations
Fluency in Microsoft Office applications (WORD, PowerPoint, EXCEL, Project)
Strong organizational and project management skills
Employer will assist with relocation costs.
Additional Salary Information: Commensurate with experience & education for the Baltimore, MD area
Internal Number: 1117
About Paragon Bioservices
We don’t just incubate new ideas, we elevate them. We pride ourselves on having some of the best minds in the business working with the most advanced technologies. We join with you, in uncommon partnership, to formulate the best approach for your needs. As unique as the concepts we cultivate, every path from the bench to the clinic, is tailored to ensure results that are timely and efficient. Results with you, for you, that deliver your success.
You can trust our dedicated staff of scientists, engineers, manufacturing associates, analysts, project managers, and quality professionals. We’re resourceful, forward-thinking, and results-driven. We immerse ourselves in your idea so that we understand it every bit as much as you do and can take on your mission as if it were our own. We know you may have just one shot at bringing the next transformative medicine to market, and we live that with you, committing our time, attention and ingenuity to delivering on your dreams of treating the untreatable and curing the incurable. We believe that’s how you become a model for the industry- a paragon.
Our track record speaks for itself. Over the past 25 years, we’ve he...lped to successfully develop and manufacture more than 50 different biotherapeutics and vaccines with our clients, creating the ideal environments in which life-changing ideas can flourish. This comes from constant evolution and innovation. It comes from providing the highest quality solutions based on cutting-edge science, logical thinking, years of experience and the passion of people invested in doing right by mankind.